Act for medical devices

NEW DELHI, JULY’16: The Union ministry of health announced last week that a Medical Device Act would be tabled in the winter session of the Parliament. The announcement came from the minister of health while taking part in a consultation convened by the Prime Minister’s Office for promoting Make in India initiative in the medical devices sector. The announcement is a long awaited one for this critical sector as it remained outside effective regulatory control of the government for several years. In fact, the Department of Pharmaceuticals had come out with a draft National Medical Device Policy in 2015 to give a proper direction to the growth of this sector in the country. The main objective of the policy is to set up a National Medical Device Authority, an autonomous body for regulating the manufacture and sales of these products in the country. The proposed Act is a step towards achieving this goal. The use of medical devices and diagnostics grew considerably in India over the last 20 years with a steady rise in lifestyle diseases among all classes of people. Medical devices or implants are routinely prescribed by doctors for heart and kidney patients, people suffering from urological problems and those afflicted by a variety of orthopedic conditions, hearing problems, etc. And almost 70 per cent of all the medical devices in terms of value are being imported into the country for years from the US, Europe as the domestic sector did not register the desired growth rate.
As the medical devices remained largely outside the purview of any regulatory control in India, there has been a large inflow of not of standard quality products into the country with very high price tags. Patients requiring these devices have no option but go for them at whatever quality and price offered by the suppliers.
There should be no doubt that medical devices have to be produced with quality materials and as per good manufacturing practices as is the case with pharmaceuticals. Quality, safety and fair pricing are three key elements that determine the growth of any industry, and that has to be the case with the medical devices also. But, in all these fronts, India’s medical device industry does not have a reputation at present. Most of the units engaged in the manufacture of medical devices in India are small and do not follow GMP voluntarily and there are no specified standards laid down by the authorities for the materials used. There has been several complaints of malfunctioning of medical devices supplied by both Indian companies and MNCs from various parts of the country. Adverse events of even critical medical devices are not being monitored in the country. The health ministry’s decision to come out with a Materio-Vigilance Programme of India (MvPI) last year is intended to ensure safety of medical devices used in the country. The objective of MvPI is to collect safety data in a systematic manner so that regulatory decisions and actions on the use of medical devices could be taken on time by the health authorities. Pricing of medical devices is yet another area where some sort of a control needs to be introduced. Currently huge margins are loaded on to the price of life saving products like drug eluting stents and other implants. The new Act and rules have to address all these aspects so that interests of all stakeholders are taken into consideration. Business Standard